Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-198-0 | CAS number: 54-21-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo insect germ cell study: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Genetic toxicity study of the test chemical
- Author:
- King et al
- Year:
- 1 979
- Bibliographic source:
- Mutation Research
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5275 (Sex-linked Recessive Lethal Test in Drosophila melanogaster)
- GLP compliance:
- not specified
- Type of assay:
- Drosophila SLRL assay
Test material
- Reference substance name:
- 2-acetyloxybenzoic acid
- Cas Number:
- 50-78-2
- Molecular formula:
- C9H8O4
- IUPAC Name:
- 2-acetyloxybenzoic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Acetylsalicylic acid
- Molecular formula: C9H8O4
- Molecular weight: 180.16 g/mol
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): The chemical was of the finest or spectroscopically pure grade
Constituent 1
Test animals
- Species:
- Drosophila melanogaster
- Strain:
- other: Berlin K
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- The test chemical was dissolved in 5% sucrose solution containing 2% DMSO if necessary
- Details on exposure:
- The test chemical was given by diet to 1-2 day old Berlin K males for 3 consecutive days, normally at the single maximally tolerated dose level (up to the LD50).
- Duration of treatment / exposure:
- 3 days
- Frequency of treatment:
- daily by diet
- Post exposure period:
- After treatment, a sequence of three brood periods (each lasting 3 days) was then initiated. At the end of each 3-day breeding period, treated males were transferred to new vials and mated individually with 3 virgin females. Typically, at least 1000 F1 females were handled in each brood.
Doses / concentrations
- Remarks:
- 0 (vehicle and 10 mM
- No. of animals per sex per dose:
- Number of males not specified but at least 1000 F1 females were handled in each brood.
- Control animals:
- yes, plain diet
- Positive control(s):
- 1,2 dichloroethane, which is a probable carcinogen in humans, was evaluated in addition to the test chemical for mutagenic effects in Drosophila.
Examinations
- Tissues and cell types examined:
- X-chromosomes
- Details of tissue and slide preparation:
- No details given.
- Evaluation criteria:
- Recessive lethal mutations frequencies in brood I, II, III, and I to III, in F2 and F3 generations, following treatment with the test chemical in males, were evaluated against solven control data using statistical analysis.
- Statistics:
- Kastenbaum-Bowman test
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Data for solvent control and for the positive control (1,2-dichloroethane at 50 mM).
Conc. |
Brood |
Days after treatment |
Number of X-chromosomes tested |
Number of lethals |
Recessive lethal mutation frequency (%) |
P values |
0 |
I |
0-3 |
9565 |
24 |
0.25 |
NS |
0 |
II |
4-6 |
6500 |
4 |
0.06 |
NS |
0 |
III |
7-9 |
5983 |
19 |
0.32 |
NS |
0 |
I-III |
0-9 |
22048 |
47 |
0.21 |
NS |
50 |
I |
0-3 |
1185 |
6 |
0.51 |
NS |
50 |
II |
4-6 |
1179 |
41 |
3.48 |
<0.01 |
50 |
III |
7-9 |
156 |
2 |
1.28 |
NS |
50 |
I-III |
0-9 |
2520 |
49 |
1.94 |
<0.01 |
NS = not statistically significant.
Note 1: The relatively low mutation frequency in brood II at 0 mM (of 0.06%) was consistent with historical control data.
Note 2: No tabular data was presented for the test chemical at 10 mM but it was concluded by the authors to be non-mutagenic in the text.
Applicant's summary and conclusion
- Conclusions:
- Three days treatment with the test chemical Drosophila at LD50 resulted in no significant increase in the frequency of sex-linked recessive lethal mutations in any of the broods or in all broods combined when compared to concurrent negative control data.
- Executive summary:
The chemical was given via diet at 0 and 10 mM for 3 days to 1-2 day old Berlin K males. A single dose of 10 mM corresponded to the LD50 value and was regarded to be the maximally tolerated dose in the insects. Treated males were mated individually with 3 Basc virgin females. A sequence of three brood periods (each lasting 3 days) was then initiated. At the end of each 3-day breeding period, treated males were transferred to new vials and mated individually with 3 virgin females. Typically, at least 1000 F1 females were handled in each brood. Sex-linked recessive lethal mutations were scored in the F2 and F3 generations. Treatment with the test chemical resulted in no significant increase in the frequency of sex-linked recessive lethal mutation in any of the broods or in all broods combined when compared to concurrent negative control data. Treatment with 1,2 dichloroethane, which is a probable human carcinogen, at 50 mM resulted in a significant increase in the frequency of sex-linked recessive lethal mutations in brood 2 and in all broods combined when compared to control data, indicating that the assay was valid for detecting mutagenic effects.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.